Daily Adaptive RadioTherapy in Postoperative HypofrActionated Salvage radiothERapy for Prostate Cancer Patients
Recruiting · NCT05884632 · Interventional (participants receive a specific treatment) · Lead sponsor: IRCCS Sacro Cuore Don Calabria di Negrar
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This is a monoinstitutional prospective pilot study, aiming to evaluate treatment-related toxicity of an hypofractionated postoperative salvage radiotherapy with daily-adaptive modality in patients affected by prostate cancer biochemical recurrence. Patients will be treated with postoperative hypofractionated salvage radiotherapy with a dose of 59 Gy in 20 fractions with daily-adaptive modality. Considering the consolidate role and clinical outcome of postoperative hypofractionated radiotherapy with elevate level of evidence (8-10), the study will not be controlled, but compared with literature data.
Who can take part
Inclusion criteria
- Age ≤ 80 years;
- Prostate cancer diagnosis, pT2-3 pN0, any resection margin (R0 or R1);
- Indication to local salvage treatment defined as: early salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA \<0.2 ng/ml or salvage radiotherapy after primary prostate surgery (radical prostatectomy) with PSA ≥0.2 ng/ml;
- No distant metastases (M0) diagnosed with PSMA-PET-CT;
- Informed consent to trial's participation and personal data treatment.
Exclusion criteria
- Age \<18 years old;
- Adjuvant radiotherapy;
- Previous radiation in the same anatomical site.
Where it is running
1 location listed.
- IRCCS Sacro Cuore Don Calabria di Negrar - Negrar, Verona, Italy